Cognitive strategy training in Post-COVID-19 Syndrome: A feasibility trial.

COVID-19 后综合症的认知策略培训：可行性试验。

• 批准号: 10712171
• 负责人: Anna Boone
• 金额: $ 43.04万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10712171
• 关键词: Achievement; Activities of Daily Living; Address; Area; Attention; Automobile Driving; Back; COVID-19; COVID-19 impact; COVID-19 long hauler; COVID-19 pandemic; COVID-19 survivors; Chi-Square Tests; Chronic; Classification; Client; Clinical Trials; Cognition; Cognitive; Communities; Compensation; Complex; Confidence Intervals; Control Groups; Coronavirus Infections; Data; Economics; Educational Intervention; Eligibility Determination; Etiology; Evidence based practice; Executive Dysfunction; Family; Foundations; Future; Goals; Habits; Health; Impaired cognition; Impairment; Improve Access; Individual; Infection; Intervention; Learning; Leisures; Life; Long COVID; Long-Term Effects; Measures; Medical; Medical center; National Institute of Child Health and Human Development; Neurobehavioral Manifestations; Neurologic; Occupational; Occupational activity of managing finances; Outcome; Outcome Measure; Outcome Study; Participant; Performance; Persons; Population; Preparation; Prevalence; Problem Solving; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Rehabilitation therapy; Reporting; Research; Research Priority; SARS-CoV-2 infection; Sample Size; Sampling; Self Management; Single-Blind Study; Stroke; Structure; Subgroup; Surveys; Symptoms; Task Performances; Testing; Time; Training; Traumatic Brain Injury; United States; Work; brain fog; cancer-related cognitive impairment; cognitive function; cognitive performance; cognitive recovery; coronavirus disease; dosage; effective intervention; executive function; experience; feasibility trial; functional improvement; improved; improved outcome; innovation; interest; intervention effect; meetings; mild traumatic brain injury; negative affect; novel; persistent symptom; post intervention; prevent; primary outcome; programs; recruit; rehabilitation research; rehabilitation service; remote administration; response; screening; secondary outcome; statistics; symptom management; symptomatology; treatment group; two-arm study

Project Summary/Abstract The long-term goal of this project is to help improve recovery from cognitive impairment associated with post- COVID-19 syndrome (PCS). PCS cognitive symptoms require the rehabilitation community to investigate ways to: (1) reduce the functional impact of the symptoms on daily life and (2) support individuals with PCS to establish new habits to improve and maintain health. The research hypothesis is that an activity-based metacognitive-strategy training intervention, the Cognitive Orientation to daily Occupational Performance (CO- OP) approach can feasibly be administered remotely and will improve activity performance, cognitive function, and quality of life in individuals with PCS. The specific aims of this study are to assess the: (1) feasibility of delivering CO-OP remotely to individuals with PCS in preparation for a future R01 trial; and (2) effect of CO-OP on activity performance, subjective and objective cognitive function, and quality of life in a sample of individuals with PCS as compared to an inactive control group. Specific aims will be completed through a single-blind, parallel, exploratory, randomized controlled trial. Individuals with PCS will be identified and asked to complete a prescreening survey to evaluate eligibility. Those meeting eligibility will undergo a baseline assessment battery. Participants (n=65) will then be randomized to a remote CO-OP treatment group (45 minutes per week for 10 weeks) or to an inactive control group. A post-intervention assessment will be completed immediately following the intervention. The purpose of this R21 is to evaluate feasibility outcomes and to obtain estimates of effect and precision of response on the outcome measures. To explore the effects of dosage on the primary outcome of activity performance, the biweekly COPM ratings will be plotted against time. Independent samples t-test and chi square test will be used to investigate differences among the two study arms and to assess whether randomization was successful. Descriptive statistics will be calculated for demographic information and the measures of intervention acceptability. Pre-to-post change in each of the outcome measures will be calculated for both groups. Cohen’s d effect size reported with precision around the estimate, 95% confidence intervals, will be used to evaluate the within and between group effects of the interventions on the primary and secondary outcome measures. The expected outcomes of this study are: (1) data to support the feasibility of remotely administering CO-OP; and (2) data to estimate effect sizes and precision of estimates of the CO-OP intervention in PCS. These data will be important for planning a future clinical trial to confirm any effects. This proposal is timely and consistent with the research priority of the National Center for Medical Rehabilitation Research (NCMRR) to identify, prevent, and treat key secondary conditions (e.g. PCS); the research program area of chronic symptom management; and the NICHD Notice of Special Interest (NOT-HD-20-03) addressing rehabilitation needs of COVID-19 survivors.

项目概要/摘要 该项目的长期目标是帮助改善与术后相关认知障碍的恢复。 COVID-19 综合征 (PCS)。 PCS 认知症状需要康复界研究方法 目的：(1) 减少症状对日常生活的功能影响；(2) 支持 PCS 患者 建立新习惯以改善和保持健康。研究假设是基于活动的 元认知策略训练干预，日常职业表现的认知取向（CO- OP）方法可以远程管理，并将改善活动表现、认知功能、 以及 PCS 患者的生活质量。本研究的具体目的是评估：（1） 向拥有 PCS 的个人远程提供 CO-OP，为未来的 R01 试验做准备； (2) CO-OP 的效果 对个体样本的活动表现、主观和客观认知功能以及生活质量的影响 PCS 组与非活动对照组相比。具体目标将通过单盲、 平行、探索性、随机对照试验。患有 PCS 的个人将被识别并要求完成 评估资格的预筛选调查。那些会议资格将接受基线评估 电池。然后，参与者 (n=65) 将被随机分配到远程 CO-OP 治疗组（每周 45 分钟） 10 周）或不活动的对照组。干预后评估将立即完成 干预后。此 R21 的目的是评估可行性结果并获得估算 反应对结果测量的效果和精确度。探讨剂量对原发性的影响 根据活动绩效的结果，将根据时间绘制双周 COPM 评级。独立样本 t 检验和卡方检验将用于调查两个研究组之间的差异并评估 随机化是否成功。将计算人口统计信息的描述性统计数据 以及干预可接受性的衡量标准。每个结果指标的前后变化将是 对两组进行计算。 Cohen 的 d 效应大小报告准确，接近估计值，置信度为 95% 间隔，将用于评估干预措施对主要和 次要结果指标。本研究的预期结果是：（1）支持可行性的数据 远程管理 CO-OP； (2) 用于估计效应大小和 CO-OP 估计精度的数据 对 PCS 的干预。这些数据对于规划未来的临床试验以确认任何效果非常重要。这 该提案及时且符合国家医学康复中心的研究重点 研究 (NCMRR) 来识别、预防和治疗关键的继发性疾病（例如 PCS）；研究计划 慢性症状管理领域；以及 NICHD 特别关注通知 (NOT-HD-20-03) 解决 COVID-19 幸存者的康复需求。